Senior Component Engineer, Medical Devices & Compliance

Diality, Inc.; Irvine (CA); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Diality, Inc. is seeking a Sr. Component Engineer to lead component governance across development and manufacturing, ensuring supply continuity and regulatory compliance in a medical device setting.

You will partner with Engineering, Quality, and Supply Chain to manage lifecycle risks, review PCNs, and qualify alternate sources, while driving cost optimization and data integrity in PLM/ERP systems. This role emphasizes cross-functional collaboration, risk mitigation, and sustaining a robust

Qualifications

• Experience working in a regulated medical device environment.
• Ability to assess supply chain risks and mitigation strategies.
• Strong communication and cross-functional collaboration.
• Familiarity with PLM/ERP systems.

Responsabilités

• Partner with Engineering to ensure component selections meet performance and supply continuity.
• Monitor lifecycle status and mitigate obsolescence.
• Support ECOs for additions, substitutions, and PCNs.
• Ensure RoHS/REACH compliance and audit readiness.
• Collaborate across Engineering, Quality, Manufacturing, and Supply Chain.

Connaissances

Regulatory compliance understanding

Analytical thinking

Project coordination

Independent work

Formation

Bachelor’s degree in Electrical, Mechanical, Industrial Engineering, or related technical field

Outils

Propel

NetSuite

Description du poste

Diality, Inc. is seeking a Sr. Component Engineer to lead component governance across development and manufacturing, ensuring supply continuity and regulatory compliance in a medical device setting.

You will partner with Engineering, Quality, and Supply Chain to manage lifecycle risks, review PCNs, and qualify alternate sources, while driving cost optimization and data integrity in PLM/ERP systems. This role emphasizes cross-functional collaboration, risk mitigation, and sustaining a robust